[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601172":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":10,"centralContacts":21,"locations":10,"responsibleParty":27,"collaborators":10,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":10,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":10,"enrollmentInfo":40,"targetDuration":10,"studyType":43,"phases":10,"briefSummary":44,"conditions":45,"keywords":10,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":10},{"fullName":5,"class":6},"Fudan University","OTHER",[8,13],{"label":9,"type":10,"description":10,"interventionNames":11},"Construction of AI models (retrospective cohort)",null,[12],"Other: No Intervention: Observational Cohort",{"label":14,"type":10,"description":10,"interventionNames":15},"Validation of AI models (prospective cohort)",[12],[17],{"type":6,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"No Intervention: Observational Cohort","No intervention",[9,14],[22],{"name":23,"role":24,"phone":25,"phoneExt":10,"email":26},"Zhengfei Zhu, PhD","CONTACT","+8618017312901","fuscczzf@163.com",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Zhengfei Zhu","Professor","100601172","multimodal-large-model-driven-risk-and-prognosis-assessment-for-brain-metastases-in-lung-cancer-100601172",false,"NCT07107035","Multimodal Large Model-Driven Risk and Prognosis Assessment for Brain Metastases in Lung Cancer","Multimodal Large Model-Driven Risk and Prognosis Assessment for Brain Metastases in Lung Cancer: A Nationwide, Multicenter, Observational Study","Inclusion Criteria:\n\n* Age≥18 years old;\n* KPS score≥70;\n* Pathologically confirmed lung cancer;\n* Receiving guideline-concordant standard-of-care therapy, defined as: radical surgical resection for early- to mid-stage non-small cell lung cancer (NSCLC); stereotactic radiotherapy for early-stage NSCLC deemed medically inoperable; radical chemoradiotherapy for locally advanced NSCLC; or systemic therapy for advanced-stage NSCLC.\n* Complete systemic imaging before treatment initiation, including contrast-enhanced brain MRI and contrast-enhanced chest CT;\n* Informed consent of the patient.\n\nExclusion Criteria:\n\n* Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);\n* Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance;\n* Physical examination findings, clinical laboratory abnormalities, or other uncontrolled medical conditions identified by the investigator as potentially interfering with study results interpretation or increasing the patient's risk of treatment complications\n* Pregnant or lactating women.","ALL","18 Years",{"count":41,"type":42},20000,"ESTIMATED","OBSERVATIONAL","The goal of this nationwide, multicenter observational study is to develop and externally validate multimodal large models that can (1) predict the risk of brain metastases and (2) estimate long-term prognosis in patients with non-small cell lung cancer (NSCLC).\n\nThe main questions it aims to answer are:\n\n* Can a multimodal large model that fuses imaging, pathology, genomic, and clinical data accurately identify NSCLC patients at high risk of developing brain metastases?\n* Can a multimodal large model reliably forecast intracranial progression-free survival, progression-free survival, and overall survival across diverse real-world treatment settings? (ie, patients receiving distinct treatment regimens, in different treatment lines and with or without intracranial local therapies).\n\nBecause this is an observational study, there are no investigational treatments; instead, researchers will compare outcomes among patients who receive standard-of-care therapies (surgery, radiotherapy, systemic therapy) to determine how well the model's predictions align with observed events.\n\nParticipants will:\n\n* Allow use of their routinely collected clinical information, imaging (chest CT, brain MRI), pathology slides, and molecular test results for model training and validation\n* Undergo standard-of-care follow-ups\n* Complete optional quality-of-life questionnaires during scheduled visits",[46,47],"AI (Artificial Intelligence)","NSCLC Brain Metastasis","NOT_YET_RECRUITING","2025-07-30",{"date":51,"type":52},"2025-08-06","ACTUAL",{"date":54,"type":42},"2025-09",{"date":56,"type":42},"2030-07",{"name":5,"class":6}]